StemCell Therapy

The latest Blue Biotechnology market study offers an all-inclusive analysis of the major strategies, corporate models, and market shares of the most noticeable players in this market. The study offers a thorough analysis of the key persuading factors, market figures in terms of revenues, segmental data, regional data, and country-wise data. This study can be described as most wide-ranging documentation that comprises all the aspects of the evolving Blue Biotechnology market.

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Blue biotechnology refers to the use of marine bio-resources as the source of biological applications. Blue biotechnology is used in various applications such as preservation of marine species, restoration of the aquatic wildlife in its original habitat. This field is also used to develop new medicines as well as conduct genetic study of plants. The increase in commercial applications of blue biotechnology has witnessed growth during the recent years, due to the adaptive nature of marine resources.

Key Players

The research provides answers to the following key questions:

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by Product (Biopolymers, Bulk Chemicals, Enzymes, Pharma Products, and Other Products); Application (Bio-Engineering, Drug Discovery, Genomics, Vaccine Development, and Other Applications); End User (Biotechnology Companies, Pharmaceutical Companies, Hospitals, Research Institutes & Laboratories, and Other End Users)

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Blue Biotechnology Market Segmented by Region/Country: North America, Europe, Asia Pacific, Middle East & Africa, and Central & South America

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Originally posted here:
Blue Biotechnology Market Insights, Future Trends, On-going Demand, Opportunities, Segmentation, and Forecast till 2027 - Jewish Life News

In the wake of increasing cases of coronavirus in the city, Panjab University has offered its services to the administration for testing Covid-19 samples.

PU registrar Karamjeet Singh, in a letter to director health services wrote, The teachers fraternity of PU can help the administration in many different areas, including testing of Covid-19 samples,

PU said the departments of microbiology and biotechnology have requisite facilities to test samples using RT-PCR instrument and the BSL-2 (biological safety level-2) laboratory with negative pressure (requirement for testing such samples).

The varsity has offered help from trained research scholars, if the administration provides them standard kits and personal protection equipment (PPE).

We have the infrastructure at our department to help the Chandigarh administration in testing Covid-19 samples, said a professor of the microbiology department.

PU vice-chancellor Raj Kumar said, During this pandemic, we feel it is our duty to assist the Chandigarh administration. Since we have the infrastructure and scientists available, we must utilise them in the public interest.

PUs BioNEST gets funds for research

Panjab Universitys BioNEST has received 6 lakh from Techinvention Lifecare Private Limited, a Mumbai-based private Biotechnology firm, for research on Covid-19.

Rohit Sharma, the project leader of BioNEST-PU said, Such collaborations help in utilising the bio-incubator as a place for dedicated research to provide services in the national interest.

See the original post:
Panjab University offers to help Chandigarh admn in testing of Covid-19 samples - Hindustan Times

Harshraj Singh

Tribune News Service

Ludhiana, March 30

After the supply of fodder for cattle has been normalised, dairy owners in city are now waiting for medicines for the treatment of sick cattle and are concerned as medicines are not available.

Since curfew has been imposed, veterinary medicine shops are closed and there is no service available to deliver medicine at dairy complexes, said the dairy owners on Tajpur Road.

Earlier, Mayor Balkar Singh Sandhu met fodder suppliers of Baranala and requested them to ensure the supply of fodder for cattle in the district. Now, dairy owners want from the concerned authorities to allow delivery of veterinary medicines at doorsteps.

The president of Tajpur Road Dairy Complex Association, DS Oberoi, said: The supply of dry fodder for cattle has been resumed. We want that medicines and feed for the cattle should also be delivered at dairy complexes. There are some veterinary medicine shops at Tajpur Road, but are closed owing to the curfew. The government should either open veterinary medicine shops or provide the shop owners with curfew passes to start delivery of required medicines at dairy complexes. If the required feed is not available, production of milk may also get affected.

Though dry fodder is being made available but the suppliers say they are unable to weigh the fodder as the stores where weighing scales are available, are closed. We request the authorities to resolve our issues so that supply of milk can be ensured, said a dairy owner.

Mayor Balkar Singh Sandhu said: After we met some farmers, they have started the supply of fodder to dairy complexes. We will take the required measures so that the delivery of veterinary medicines can also be ensured at the earliest.

Originally posted here:
Dairies demand doorstep delivery of vet medicines - The Tribune

The Conference of Research Workers in Animal Diseases held its 100th annual meeting Nov. 2-5 in Chicago. The city of Chicago marked the occasion with a proclamation honoring CRWAD and its years of work.

Since the first CRWAD meeting convened in 1920as a closed gathering of 11 individuals, mostly directors of experiment stations and deans of U.S. veterinary schoolsthe conference has evolved into the premier international event on animal health and disease research.

More than 700 scientists attended the 100th annual CRWAD meeting, which featured 17 featured speakers and 270 oral and 220 poster presentations.

Leadership

The 2019 CRWAD officers were Qijing Zhang, PhD, Iowa State University, president; Dr. Amelia Woolums, Mississippi State University, vice president; Dr. Christopher Chase, South Dakota State University, immediate past president; Dr. Paul Morley, West Texas A&M University, executive director; and council membersDr. M.M. Chengappa, Kansas State University; Charles Czuprynski, PhD, University of Wisconsin-Madison; Dr. Annette OConnor, Michigan State University; and Dr. Philip Griebel, University of Saskatchewan.

AAVI awards

The American Association of Veterinary Immunologists recognized Dr. Bettina Wagner, Cornell University, as the 2019 AAVI Distinguished Veterinary Immunologist.

Recipients of the AAVI student awards for best oral presentations were as follows: Alexandra Gillespie, University of Massachusetts; Carsten Walker, Michigan State University; Jayne Wiarda, Iowa State University; Elizabeth Larson, Cornell University; and Amanda Amaral, North Carolina State University. Best poster presentation was awarded to Shauav Bhattarai, South Dakota State University.

ACVM awards

The American College of Veterinary Microbiologists named Dr. T.J. Nagaraja, Kansas State University, as the 2019 Distinguished Veterinary Microbiologist.

ACVM student award winners were as follows: Don Kahn Award for best overall presentationDebra Goulart, Iowa State University; best oral presentationsSara Raabis, University of Wisconsin-Madison, and Syeda Hadi, Michigan State University; best poster presentationF. Yuan, Kansas State University.

AVEPM awards

The Association for Veterinary Epidemiology and Preventive Medicine presented the Mark Gearhart Memorial Graduate Student Award for best overall graduate student research to Dr. Gizem Levent, Texas A&M University.

Sam Rowe, University of Minnesota; James Ogunrina, Texas A&M University; and Casey Cazer, Cornell University, received awards for best oral presentations. Sneha Jha, Purdue University, won best poster presentation.

Animal Health Institute and Joseph J. Garbarino Foundation

Best oral presentation was by Ting-Yu Cheng, Iowa State University, and best poster presentations were by Emily John, University of Prince Edward Island, and Babiana Benavides, University of Narino.

American Association of Veterinary Parasitology awards

The best oral presentation was presented by Megan Wright, University of Tennessee.

NC1202 awards

The NC1202 North Central Multistate Committee for Research on Enteric Diseases of Swine and Cattle made the following student awards: Lynn Joens Award, first place, oralRaquel Burin, Washington State University; second place, oralFrances Shepherd, University of Minnesota.

The David H. Francis award for best poster presentation was given to Brandon Ruddell, Iowa State University.

Continue reading here:
CRWAD marks 100th annual meeting | American Veterinary Medical Association - American Veterinary Medical Association

The new coronavirus, SARS-CoV-2, has many people staying at home except for essential activities like seeking medical care, exercising, walking their dog, or shopping for groceries.

You can reduce your risk of exposure to COVID-19 whenever you leave your house by taking precautions such as practicing social distancing and washing your hands thoroughly and often.

Shopping for groceries, though, carries extra risk.

Not only are you near other people, but many of the products youre buying have probably been handled by others and possibly sneezed or coughed on.

This doesnt mean you should give up on trips to the supermarket. Thats not really a viable option for most of us.

But you can take a little extra care when handling your groceries to avoid spreading the virus to other people and surfaces in your house.

Charlotte Baker, DrPH, MPH, an assistant professor of epidemiology at Virginia-Maryland College of Veterinary Medicine in Blacksburg, Virginia, said your biggest risk at the supermarket is coming into close contact with another person whos sick.

Thats why its important to stay at least 6 feet from other people at all times.

Do not be afraid to ask others to step back if they are too close to you in line, said Baker. Or wait a few moments to grab something if others are already by the item you want.

Its not clear, though, how much of a role produce and food packaging plays in transmitting the virus that causes COVID-19.

Still, the World Health Organization says that in addition to close person-to-person contact, people can pick up the virus by touching contaminated surfaces and then touching their eyes, nose, or mouth.

Some surfaces may pose a bigger risk than others.

A recent study in the New England Journal of Medicine found that the virus was detectable on plastic and stainless steel for up to 72 hours, and on cardboard for up to 24 hours.

Baker said when youre at the supermarket, you should assume all surfaces everywhere have been touched by someone who is sick.

This includes produce and packaged foods.

Touch just the items you intend to buy, wipe down the cart or basket handles with disinfectant wipes, and wash your hands or use hand sanitizer when youre done, she said.

Baker added that many people are also reducing their potential exposure by using curbside pick-up or at-home delivery. Even local food producers are offering these services.

Some farmers markets are allowing customers to preorder foods so they are already packaged when you come pick them up, she said, reducing the amount of time that you need to be near other people and reducing the amount of items that you can touch.

Whichever way you get your groceries, youll want to handle them carefully when you get them home. This will reduce the chance of spreading the virus to other people or surfaces in your house.

Elizabeth L. Andress, PhD, a professor of foods and nutrition at the University of Georgia, said at the very least you should wash your hands after unpacking and putting away your groceries.

If youre concerned about potential contamination on your groceries, you can take additional steps to protect yourself.

Some people may choose to wipe or wash cans and boxes of food before storing them to reduce possible virus content, said Andress. You can also throw out disposable packaging.

When youre done, she suggests that you wash any tables, countertops, or other surfaces that were touched by your groceries or grocery bags.

And wash your hands again.

The Centers for Disease Control and Prevention (CDC) offers advice for cleaning and disinfecting your home during the pandemic, including which cleaners work best against SARS-CoV-2.

If youre using cloth bags, wash them with laundry soap in a washing machine and dry them thoroughly before reusing them.

If you or someone in your household is at higher risk for severe illness from COVID-19, you might want to adopt the modified sterile technique recommended by Dr. Jeffrey VanWingen, a family physician practicing in Grand Rapids, Michigan, in this YouTube video.

VanWingen said that one option is to leave your groceries in your garage or porch for at least 72 hours to allow the virus to become inactive.

This isnt possible for many people. For them, he suggests the sterile technique. You can also do this after letting your groceries sit outside for 72 hours.

A key part of VanWingens method is setting up a cleaning station to avoid contaminating your food or other surfaces in your house.

After that, it involves wiping down all packaging with a disinfectant before putting your groceries away. You can also discard packaging and transfer the food to a clean bag or container.

For fruits and vegetables, VanWingen suggests scrubbing them for at least 20 seconds with soap and water.

Andress cautions that the Food and Drug Administration doesnt recommend using soap when cleaning produce because of the risk of ingestion.

So if you choose to use soap and water on your fruits and vegetables, rinse them completely with clean water before storing.

Taking these precautions with your groceries can help you lower your chance of being exposed to the virus.

If you do get sick, youll need to take extra care in order to protect your family.

If someone in your household is confirmed positive with COVID-19, showing symptoms of the disease, or awaiting the results of a test, they should take extra cleaning and disinfection steps around the home, said Andress.

Continued here:
How to Decontaminate Groceries During the COVID-19 Outbreak - Healthline

Centers for Disease Control and Prevention officials see no evidence that the coronavirus that causes COVID-19 in people sickens pets or can spread to people through pets.

But the agency is advising, out of an abundance of caution, that people who become sick with the coronavirus should limit contact with their companion animals, just as they should limit contact with people. World Health Organization officials also indicated they saw no evidence pets have become ill with or could spread the virus.

Meanwhile, the AVMA and government agencies continue to monitor the availability of medical supplies and animal drugs as well as other potential impacts to the profession as the virus continued to spread in the U.S. in the first few months of the year. A number of universities and organizations cancelled classes and events to allow for social distancing.

When possible, have another member of your household care for your animals while you are sick, according to a CDC FAQ document updated in February to add information on animals. If you are sick with COVID-19, avoid contact with your pet, including petting, snuggling, being kissed or licked, and sharing food. If you must care for your pet or be around animals while you are sick, wash your hands before and after you interact with pets and wear a facemask.

Though the virus seems to have emerged from an animal source, CDC officials also saw no evidence that animals or animal products arriving from China or elsewhere pose a risk of spreading the COVID-19 virus in the U.S. More information is available at jav.ma/cdc_covid.

Late in February, authorities in Hong Kong reported that they quarantined a pet dog after its owner was hospitalized because of COVID-19, and nasal and oral cavity samples tested weak positive for the COVID-19 virus. Four subsequent nasal samples continued to test weak positive, but test results for nasal samples collected on March 12 and 13 came back negative. The regions Agriculture, Fisheries and Conservation Department said the results suggested a low-level infection likely acquired from a person, and they said World Organisation for Animal Health (OIE) officials agreed with their findings.

The dog has not shown any signs of disease related to COVID-19, Hong Kong authorities said. The companion animal was returned to the owner after completion of quarantine and consecutive negative test results. The dog, identified by the South China Morning Post as a 17-year-old Pomeranian, died on March 16, the department said in an email, citing the animals owner. The AFCD gave no further details.

OIE officials separately characterized the positive nasal sample results as presence of genetic material from the COVID-19 virus and said the organization lacks evidence dogs become sick from the virus or play a role in disease spread.

On March 19, Hong Kong authorities said they quarantined two more dogsa German Shepherd Dog and a mixed-breed dog whose owner had COVID-19after a polymerase chain reactionbased assay detected COVID-19 virus in a sample from the German Shepherd Dog but not the other dog. Neither dog showed clinical signs of disease.

Idexx Laboratories Inc. announced March 13 that it has seen no positive results to date of SARS-CoV-2 in pets. Idexx evaluated thousands of canine and feline specimens during validation of a new veterinary test system for the COVID-19 virus, according to a company press release. The specimens were obtained from those submitted to Idexx reference laboratories for PCR assay testing.

The company says if health authorities determine it is clinically relevant to test pets, it will make the test system available, but neither the CDC nor the AVMA is recommending that pets be tested at this time. Dogs or cats with respiratory signs should be evaluated by a veterinarian for more-common respiratory pathogens before looking to evaluate them for COVID-19, according to an AVMA FAQ for veterinarians and veterinary clinics.

On March 19, Antech Diagnostics announced that it also has not detected any evidence of SARS-CoV-2 in samples from dogs and cats.

Since February, AVMA leaders have been working with the CDC, the Food and Drug Administration, the U.S. Department of Agriculture, and other experts and international disease authorities to gather the latest information on the coronavirus for veterinarians, clients, and patients, available at avma.org/coronavirus. Aside from keeping veterinary team members healthy, ensuring as much access to care for ill patients as possible, and other concerns, AVMA leaders are worried about potential drug shortages as COVID-19 disrupts supply chains, especially because six of the 32 companies that produce animal-use drugs in China or that use active ingredients from China to produce drugs for the U.S. market indicated to the FDA they have seen disruptions that could lead to shortages.

No animal drug shortages were reported as of mid-March.

The website notes that FDA officials were working with the companies to find ways to mitigate shortages, and the AVMA was collecting information on drug needs and veterinarians concerns. The AVMA is asking that veterinarians send information on supply chain issues to coronavirusavma [dot] org, with details on the products and their manufacturers or distributors.

FDA officials also forecast short supplies of personal protective equipment such as surgical masks, gowns, and suits, as well as isolation gowns.

Guidance from the FDA on surgical mask and gown conservation strategies is available at jav.ma/masks.

As cases of COVID-19 ramped up over the beginning of March, academic institutions reacted by taking greater precautions to slow the spread of the COVID-19 illness.

The 50th Annual Student AVMA Symposium, slated for March 14-16 at Cornell University College of Veterinary Medicine in Ithaca, New York, was canceled after organizers conferred and the university called off all nonessential events or work-related gatherings scheduled between March 9 and April 15 that involved more than 100 people.

Student organizers were working with college leadership to identify ways to provide recorded lectures for registrants to view, according to a post on the events website.

The Veterinary Innovation Summit, which was to be held April 3-5 at Texas A&M University College of Veterinary Medicine & Biomedical Sciences, was also canceled because of caution over COVID-19. All registration fees were to be refunded and cancellation fees waived.

Many universities with veterinary colleges announced in mid-March that they were suspending face-to-face instruction and testing for various lengths of time during the spring semester to allow for social distancing. Instead, universities encouraged educators to move their courses online and to prepare to continue that way as long as in-person instruction seemed inadvisable, potentially through the end of the semester.

Many clinical rotations were being cancelled and veterinary teaching hospitals were curtailing operations to enable social distancing, according to a March 15 announcement from the Association of American Veterinary Medical Colleges. Schools are working with students who are in clinical rotations and externships on an individual basis to re-assign them or make alternative arrangements as needed, the announcement said.

The AAVMC also noted that its impacted member institutions were working with the AVMA Council on Education to ensure they maintain the highest quality of education during this time.

The COE requires schools to report any disruption to the educational program lasting two or more weeks and to describe their plans to remediate the disruption. The COE is reviewing these plans to ensure they are in compliance with the standards of accreditation, the announcement said.

See more here:
No evidence pets can become ill with COVID-19 virus as it surges in US - American Veterinary Medical Association

VALLEY COTTAGE, N.Y. Veterinary orthotics and prosthetic devices are increasing used for injured animals. Orthotics are a medical device which is attached to the body of an injured animal to provide support, align, position, immobilize, prevent or correct deformity, assisting weak muscles, or improving functions. Prosthetics are defined as medical devices which are used to compensate for a missing or amputated leg segment. Owing to the current advancements in the veterinary orthotics-prosthetics market, it is no longer necessary to amputate an entire leg when the only lower body is injured; partial amputation is sufficient in many cases.

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Veterinary Orthotics-Prosthetics Market: Segmentation

Veterinary Orthotics-Prosthetics marketcan be segmented on the basis of various product types available for the rehabilitation of injured animals:

Preview Analysis ofVeterinary Orthotics-Prosthetics Market: Global Industry Analysis 2012 2016 and Opportunity Assessment; 2017 2027:https://www.futuremarketinsights.com/reports/veterinary-orthotics-prosthetics-market

On the basis of diagnosis of the end users, we can segment the veterinary orthotics-prosthetics market into:

Veterinary Orthotics-Prosthetics Market: Dynamics

The veterinary orthotics-prosthetics market is a growing market owing to the rising awareness regarding the treatment options available to rehabilitate the animals. Canine rehabilitation has made advancements in the modern veterinary medicine with the advent of various research institutions. The market for veterinary orthotics-prosthetics is driven by improving the quality of life, functional independence, preventing euthanasia among others. However, low support from the government and non-profit organizations has restricted the growth of the market. Veterinary orthotics-prosthetics market witnesses innovations in prosthetic device technology, customization in prosthetic devices, and consolidation of the global veterinary orthotics-prosthetics market.

Veterinary Orthotics-Prosthetics Market: Region-wise Outlook

Based on geography, the Veterinary Orthotics-Prosthetics Market can be segmented into five major regions: North America, Europe, Asia-Pacific, Latin America and Middle East & Africa. At present, North America holds a leading position in the Veterinary Orthotics-Prosthetics Market followed by Europe. The major driving factors which have driven the growth of the Veterinary Orthotics-Prosthetics Market in these regions are the fast paced services and fulfillment of custom requirements for the manufacturing of orthotics-prosthetics products. Following North America, European countries are also anticipated to show steady growth in the Veterinary Orthotics-Prosthetics Market. In the next few years, Asia-Pacific would show remarkable growth in the Veterinary Orthotics-Prosthetics Market as it is developing at a very rapid pace and has shown the emergence of many regional players. The factors which would fuel the growth of Veterinary Orthotics-Prosthetics Market in Asia-Pacific are increasing awareness regarding animal care and rehabilitation services and rapid development of the healthcare infrastructure across the Asian countries. Veterinary Orthotics-Prosthetics Market would evolve at a rapid rate across the regions. However, North America would maintain its position in the overall Veterinary Orthotics-Prosthetics Market.

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Veterinary Orthotics-Prosthetics Market: Key Players

It is expected that with due course of time, there will be an influx of well-established players in the Veterinary Orthotics-Prosthetics Market. Some of the major service providers operating in the Veterinary Orthotics-Prosthetics Market is OrthoPets LLC., Animal Ortho Care, AAA Orthotics and Prosthetics, Anchor Orthotics & Prosthetics, Animal Care Castle Rock OrthoPets Castle Rock, Appletree Orthotic Services Ltd, Animal Orthocare, Avondale Veterinary Healthcare Complex OrthoPets Iowa, Buddy Braces, Dogs in Motion Canine Rehabilitation OrthoPets Australia, Equisport Medicine OrthoPets Washington, HandicappedPets.com, Hanger Clinic, Holisticvet OrthoPets South Africa, J.G. McGinness Prosthetics & Orthotics, K-9 Orthotics & Prosthetics, A Loyal Companion OrthoPets Arizona, M.H. Mandelbaum Orthotic & Prosthetic Services, My Pets Brace, Ortho Design, OrthoPets Europe, OrthoVet, LLC, PALS Pet Artificial Limbs & Supports, Pawsitive Steps Rehabilitation Clinic OrthoPets Michigan, PawsAbility, Paws on the Go OrthoPets Southern California, Paws to Embrace, Petsthetics, LLC, Wheat Ridge Veterinary SpecialistsPosh Ortho Dog Inc., Santoro & Sons, Sierra Orthopedic Lab, Veterinary Inclusive Prosthetics/Orthotics (VIP) and Veterinary Orthopedic and Sports Medicine Group (VOSM). Veterinary Orthotics-Prosthetics Market has a presence of many regional players manufacturing customized which have a huge market share in emerging countries.

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Originally posted here:
Veterinary Orthotics Prosthetics Market Prophesied to Grow at a Faster Pace by 2027 - PharmiWeb.com

A domestic cat in Belgium has been infected with COVID-19, the disease caused by the new coronavirus that's spreading across the globe, the government's FPS Public Health, Food Chain Safety and Environment announced March 27, according to news reports.

This is the first human-to-cat transmission of the novel coronavirus (SARS-CoV-2). About a week after its owner got sick with COVID-19, after returning from a trip to Northern Italy, the cat developed coronavirus symptoms: diarrhea, vomiting and respiratory issues, Steven Van Gucht, virologist and federal spokesperson for the coronavirus epidemic in Belgium, told Live Science.

The owner sent samples of vomit and feces to Dr. Daniel Desmecht's lab at the Faculty of Veterinary Medicine of Lige. Genetic tests showed high levels of SARS-CoV-2 in those samples, he said. "The cat recovered after 9 days," Van Gucht said.

Related: 13 Coronavirus myths busted by science

Cats and humans appear to have a similar "doorknob" on the surfaces of respiratory cells that lets the SARS-CoV-2 virus get inside, according to Van Gucht.

In humans, scientists have figured out that the SARS-CoV-2 virus attaches to a receptor protein called ACE2 that's on the outside of respiratory cells. Once inside of these cells, the virus hijacks certain machinery so it can replicate.

"The feline ACE2 protein resembles the human ACE2 homologue, which is most likely the cellular receptor which is being used by Sars-CoV-2 for cell entry," Van Gucht said.

During the 2003 SARS outbreak, cats were infected with a coronavirus as well, Van Gucht said.

The only other pets thought to have "caught" the novel coronavirus from owners were two dogs in Hong Kong. The first dog, a 17-year-old Pomeranian, tested a weak positive for the virus at the end of February, Live Science reported. The dog died in mid-March, though the exact cause of death is not known, as the owner didn't allow an autopsy.A second dog, a German shepherd, tested positive but showed no symptoms of the disease, Bloomberg reported.

During the outbreak of another coronavirus, severe acute respiratory syndrome (SARS), dogs and cats contracted low levels of that virus, animal health expert Vanessa Barrs from City University told the South China Morning Post.

There have been no reports of pets passing the virus to their human owners, and Van Gucht stressed that even human-to-pet transmission is not a significant path of viral spread.

"We think the cat is a side victim of the ongoing epidemic in humans and does not play a significant role in the propagation of the virus," he said.

To prove definitively that the cat was infected with SARS-CoV-2, scientists will need a blood test to look for antibodies specific to this virus, Van Gucht said. Those tests will happen once the cat is no longer under quarantine.

Originally published on Live Science.

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Cat infected with COVID-19 from owner in Belgium - Livescience.com

Over 95% planned enrollment completed in Phase 3 oGVHD study; topline results anticipated by end of 2020

MALVERN, PA Ocugen, Inc. (NASDAQ: OCGN), a clinical-stage company focused on discovering, developing and commercializing transformative therapies to treat rare and underserved ophthalmic diseases, recently reported full year 2019 financial results along with a general business update.

We are extremely pleased with the progress we have made in enrolling patients in our Phase 3 clinical trial for OCU300, an orphan drug candidate for ocular graft versus host disease (oGVHD). Based on current enrollment, we anticipate topline results by the end of the year, commented Shankar Musunuri, PhD, MBA, Chairman, CEO and Co-Founder of Ocugen.

The publication of preclinical data on OCU400 inNature Gene Therapyearlier this month is a key achievement for this program. We continue to advance IND-enabling studies toward bringing this potential breakthrough modifier gene therapy platform to patients in a Phase 1/2a clinical trial for OCU400 in 2021.

Similar to the situation with virtually all other biopharmaceutical companies, we are also assessing the potential impact of ongoing COVID-19 pandemic-related events on our programs and plans. We are grateful to healthcare professionals and others who are working hard to address and mitigate the challenges presented by the virus.

Business Highlights:

Full Year 2019 Financial Results:

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Ocugen Provides Business Update and Full Year 2019 Financial Results - MyChesCo

Glen Allen Mar 30, 2020 (Thomson StreetEvents) -- Edited Transcript of Precigen Inc earnings conference call or presentation Monday, March 2, 2020 at 10:30:00pm GMT

Precigen, Inc. - President & CEO

Precigen, Inc. - VP of IR

H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst

Good day, and welcome to the Precigen Conference Call. (Operator Instructions) Please note that this event is being recorded. I would now like to turn the conference over to Steven Harasym. Please go ahead, sir.

Steven Harasym, Precigen, Inc. - VP of IR [2]

Thank you, operator. Welcome to the Precigen Fourth Quarter and Full Year 2019 Business and Update Call. I'm Steven Harasym, Vice President of Investor Relations. And I'm pleased to be joined today by Dr. Helen Sabzevari, President and CEO of Precigen; and Tom Samuelson, Vice President of Finance.

During today's call, as seen on Slide 2, we will make various forward-looking statements. Investors are cautioned that our forward-looking statements are based on current expectations and are subject to risks and uncertainties that could cause actual results or outcomes to differ materially from those indicated by our forward-looking statements. Please read the safe harbor statement contained in this presentation as well as in Precigen most recent SEC filings for a more complete discussion of these risks and uncertainties. I would now like to turn the call over to Dr. Helen Sabzevari. Helen?

Helen Sabzevari, Precigen, Inc. - President & CEO [3]

Thank you, Steve. Please go to Slide 3. I'm extremely pleased to be here today as we have made great progress even since our last public presentation at JP Morgan Health Care Conference in early January. We enter 2020 with renewed optimism about our ability to deliver on our aggressive goals and add value to shareholders.

Precigen's mission is to improve patient care through innovative gene and cell therapy-based approaches. I will review our carefully curated portfolio of unique solutions to unmet needs in health in greater detail. Our approaches are novel and designed to treat conditions that are both difficult to treat and have limited treatment options for patients.

Before we give a quick recap of the divestments and transactions that enabled us to advance towards our goal of becoming a dedicated health care company, I thought it would be useful to provide a recap of how far we have come in such a short time, as shown in Slide 3. In Q4 of 2018, we started on the path to becoming a stand-alone health care company by reacquiring the rights to our oncology assets from our former partners. In just under a year, we advanced 2 programs from inception into the clinic and developed a pipeline of promising product candidates in immuno-oncology, autoimmunity and infectious diseases. We also took the necessary steps to expand on an already robust IP estate. Finally, we consolidated the majority of our operation in our Maryland headquarters and continue to bolster our scientific team here.

We believe the transactions that occurred over the last several months put us firmly on the path to being able to devote our resources to advance our health care assets and become a major player in the gene and cell therapy field. As you may recall, this included divesting the majority of Intrexon's non-health care assets, my appointment as a CEO, and name change from Intrexon to Precigen, and associated stock ticker change to PGEN. We also sold our position in AquaBounty for approximately $21.6 million; sold our 50% interest in EnviroFlight to our former partner, Darling Ingredients for $12.2 million; completed the sale of several assets, including our non-health subsidiaries, Oxitec, Okanagan Specialty Fruits and AgBio and ILH Holdings for a combined $53 million-plus certain contingent payment rights. These now divested non-health businesses accounted for $46 million in net cash operating expenses and capital expenditure in 2019 and raised $35 million in capital through the issuance of equity.

Through the financial transaction, we achieved our previously stated cash position goals, allowing the company to deliver on several value-creating milestones in 2020. Furthermore, we are happy to report that the going concern qualifier has been removed from our financial statement. Based on a combination of our cash position and reduced spending, we anticipate current capital on hand will allow us to operate well into 2021.

In light of our transition to a more health-focused company, we are evaluating all aspects of our operating structure and will provide updates in our next quarterly call. Concurrently, I want to acknowledge the contributions of General Bostick, COO and President of Intrexon Bioengineering; and Tom Reed, Founder and CFO of Intrexon, both of whom are no longer at the company. We thank them for their contribution and services.

Moving ahead, I want to share how we plan to manage Precigen going forward on the next slide. Slide 4, please. With our focus firmly on health care, we have aligned the entire company to operate in accordance with 4 key principles. First is adhering to strict fiscal responsibility. We will responsibly allocate capital to maximize value creation for stakeholders. Fiscal responsibility for us is not just about saving, maintaining cash and cutting costs. It is also about allocating resources to the right areas to create value. You will note that in 2019, we spent $43.7 million on our 2 most advanced health care subsidiaries, Precigen and ActoBio. Collectively, the health portfolio spent significantly lower than our non-health portfolio.

The second operating principle is actively managing our portfolio with a strict adherence to data-driven go and no-go decisions. Third is focusing on rapid execution, moving our valuable portfolio of assets quickly into the clinic and advancing them into registration-enabling studies in accordance with the appropriate scientific, clinical and manufacturing standards. And finally, forming a strategic partnership to advance or divest assets in our portfolio where appropriate, noting our fiduciary duty to operate in the best interest of shareholders.

Since January, we have aligned our portfolio, streamlined our operations and optimized our organizational structures to improve operational efficiency, especially at the corporate level. We will continue to take additional efficiency measures across the organization, and we'll update you on our progress. I strongly believe that the most important way we can deliver value to shareholders is to create value to patients through rapid development of novel therapeutics that are safe, effective and address unmet medical needs in a fiscally responsible manner.

Before moving on to a review of the anticipated 2020 milestones for Precigen, on the next slide, we want to discuss our strategy for the remaining non-health assets. Slide 5, please. Our subsidiary MBP Titan's technology platform has the potential to upgrade natural gas to higher value carbon output through our Methane Bioconversion Platform. As we prioritize our health portfolio, the Board of Directors and I are committed to significantly reducing our non-health spending, specifically for MBP.

To this end, we have already implemented efficiency measures at MVP to achieve this goal and have already significantly reduced their capital requirements compared to last year. We will continue to evaluate further efficiency measures that support its ongoing operations while establishing clear fiscal guardrails on spending.

Our goal is to partner or ultimately sell this business. Whatever we do will be in the long-term interest of our stakeholders and adherence to our mission. We will continue to update you on our decision when we have new information to share.

Another non-health business in our portfolio, Trans Ova, is the industry leader in advanced reproductive technologies for the cattle industry. We considered divestiture of this non-health business, but ultimately elected to retain it because we believe it has more value than the offers we received.

Nevertheless, we continue to strategically evaluate options for this business. In the meantime, however, we have implemented efficiency and cost reduction measures, such that we will not contribute any additional capital towards Trans Ova and expect Trans Ova to return to being a net contributor of capital to Precigen this year.

Moving to the next slide. You can see the breadth of our health care organization. Slide 6, please. The new Precigen enters 2020 with a promising portfolio of investigational gene and cell therapies. Under the new 1 Precigen umbrella is our transformative UltraCAR-T, AdenoVerse immunotherapy and ActoBiotics Therapeutic platforms, which share a focus on developing innovative therapies in immuno-oncology, infectious diseases and autoimmune disorders. We also are advancing an innovative approach from our subsidiary, Triple-Gene, in heart failure.

Slide 7, please. Moving to the next slide, we see the breadth and the value of our clinical portfolio, which includes our internal as well as partnered programs, including later-stage assets in Phase II and Phase III clinical trials. Two important things to remember about our portfolio are that: first, we are advancing unique programs that represent substantial therapeutic class innovation; and second, we expect most of these programs to have important data readouts in 2020.

Following the release of new data, we intend to assess and further prioritize our pipeline to optimize cash resources. Beyond this clinical pipeline, we also have a portfolio of novel preclinical assets that will be assessed and funded according to strict science and data development analysis. Our most significant role for preclinical assets for 2020 is to initiate a Phase I trial of PRGN-2009, our new off-the-shelf AdenoVerse immunotherapy in HPV-positive cancers.

Slide 8, please. Before reviewing our many exciting milestones for 2020, I want to take a few moments on the next slide to provide an overview of one of our most promising therapeutic platforms, UltraCAR-T. We believe it holds the promise to revolutionize the CAR-T landscape and provide benefits to patients and the health care system at large for the following reasons. First, unlike conventional CAR-T, UltraCAR-T cells do not require lentivirus and long ex vivo expansion in manufacturing facilities. Instead, UltraCAR-T uses nonviral, rapid, overnight manufacturing at hospital. This overnight manufacturing brings the potential for repeat dosing of UltraCAR-T to patients as well. This manufacturing approach, we believe, brings the convenience of allogeneic CAR-T administration to autologous CAR-T treatment without the potential risk associated with the allogeneic CAR-T therapy.

Second, unlike conventional CAR-T, UltraCAR-T cells express membrane-bound IL-15, which provides higher potential to expand and persist in vivo and to maintain a younger, less differentiated state.

Conventional CAR-T cells have limited potential for expansion after administration due to long manufacturing process that requires T cell activation and expansion outside the body.

Allogeneic CAR-T cells are even more limited in their persistence potential since they are foreign and risk rejection by patients' immune system and the occurrence of the graft-versus-host disease.

Furthermore, allogeneic CAR-T cells requires severe lymphodepletion of patients, which also limits antigen-spreading potential. We believe membrane-bound IL-15 provides our UltraCAR-T cells with a higher potential for expansion and persistence in patients after administration than conventional CAR-T.

Third, we have built our UltraCAR-T platform such that all modified T cells express a kill switch. This engineering provides us with an ability to selectively eliminate UltraCAR-T cells by administration of a kill switch activator in the event of toxicity, thus improving the safety profile.

With the potential to advance precision medicine and disrupt the current CAR-T landscape, our vision for the UltraCAR-T platform is to build and validate a library of UltraCAR vectors to provide personalized autologous CAR-T treatment for any cancer patients in a rapid and cost-conscious manner. During 2020, we expect to report numerous data sets and achieve new milestones.

Slide 9, please. Looking at our advanced assets,

3005 is the first UltraCAR-T in solid tumors, targeting ovarian cancer in Phase I clinical study. We currently are enrolling the second cohort for the IP arm. To date, we continue to have 100% manufacturing success and the preliminary findings regarding UltraCAR-T kinetics, which includes expansion and persistence in patients treated in the lowest dose cohort are very encouraging. We know that everyone is eager to see these early data points, and we share their excitement. We will continue to evaluate the appropriate time to provide additional details. Presently, we expect to provide an initial readout from the IP arm in the second half of 2020. We are also planning to present preclinical data for 3005 at an upcoming medical meeting later this year.

Slide 10, please. 3006 is the first UltraCAR-T therapy be evaluated in hematological cancers. We recently received orphan drug status from the FDA for this program. We are currently enrolling the second cohort for the non-lymphodepletion arm and the first cohort for the lymphodepletion arm. As with 3005, we continue to have 100% manufacturing success and the preliminary findings regarding UltraCAR-T kinetics from the trial are very encouraging. We expect to provide an initial data readout in the second half of 2020.

We are very excited about the Phase II trial for AG013 for oral mucositis in head and neck cancer with our partner Oragenics as we believe that it will further validate our ActoBiotics platform across multiple indications. Using our platform in partnership with Oragenics, we are targeting oral mucositis, a severe and painful side effect of chemoradiation therapy, especially in patients with head and neck cancer. There are currently no drugs approved to prevent this condition in the cancer patient population. As a result, the FDA has given this program Fast Track status, which validates the urgent need for a treatment. AG013 is formulated as an oral rinse and used as mouthwash to deliver the trefoil factor 1 gene, which prevents mucosal tissue damage and induces subsequent repair of the lining of the mouth. Based on the encouraging Phase I data, AG013 is currently in a Phase II trial. Enrollment in this study was completed in the fourth quarter of 2019, and we are looking forward to reporting interim data from the Phase II trial in the first half of 2020. We also expect to report interim data from an ongoing clinical trial of AG019 in type I diabetes patients. AG019 is a first-in-class disease-modifying antigen-specific immunotherapy for the prevention, delay or reversal of type 1 diabetes with encouraging results in preclinical studies. Currently, AG019 is in a Phase Ib/IIa trial. The Phase IIa portion of the trial is now enrolling, and interim data readout is expected in the third quarter of 2020.

Another exciting asset in our portfolio is INXN-4001, a novel gene therapy for heart failure patients, which is being developed by our majority-owned Triple-Gene subsidiary. We expect to complete the trial by the end of 2020. 2009 is an off-the-shelf AdenoVerse immunotherapy product candidate designed to activate the immune system to recognize and target HPV-positive solid tumors. This program is currently under development through a Cooperative Research and Development Agreement or CRADA with Dr. Jeffrey Schlom, a world renowned investigator in immuno-oncology at the NCI. We expect the NCI to start dosing patients in 2020.

I'll now turn the call over to Tom Samuelson to provide a financial update.

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Tom Samuelson, [4]

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Thank you, Helen, and good evening, everyone. There are 3 key points that I would like to address today. First, as Helen mentioned, we've made material progress in narrowing the company's focus to our core health care programs and reducing our other capital requirements. A critical component of this pivot was the divestiture of a number of our legacy bioengineering assets, including our shares in AquaBounty for $86.8 million plus certain contingent payment rights, and the sale of $35 million of our common stock. The business is sold in these recent transactions accounted for $46 million in 2019 segment adjusted EBITDA losses, capital that can be redeployed towards our health care assets in 2020. Please recall that segment EBITDA, which is more fully defined in our 10-K, is generally the sum of net cash operating expenses and capital expenditures. The proceeds from these transactions, combined with the company's cash and short-term investments on hand, provide sufficient capital to remove the going concern qualification from our 2019 financial statements. We've adjusted our 2019 and prior financial statements to reflect the effects of these businesses as discontinued operations.

Second, we reported fourth quarter and full year 2019 revenues of $17 million and $90.7 million and consolidated financial results from continuing operations, as we continued our shift from the business model focused on collaboration and licensing revenues to one wholly focused on our internal programs primarily in human health. Despite pivoting away from a collaboration model, we continue to own the rights to certain legacy milestones and royalties. Any of these, if successful, could result in additional sources of capital for us without requiring any further obligations on our part.

Fourth quarter and full year segment EBITDA losses including corporate costs, were $37.8 million and $144.4 million, respectively. These annual losses included only $30.2 million at Precigen and $13.7 million at ActoBio. Among our retained bioengineering entities, MBP Titan and Trans Ova Genetics accounted for $36.7 million and $6.3 million, respectively. As Helen mentioned, we are fully committed to reducing spend at these entities and have already implemented efficiencies that should substantially reduce their capital requirements going forward. I would further highlight that the aforementioned $46 million in segment EBITDA losses from transacted assets does not include an allocation of general corporate costs, which we do not allocate to particular segments. More details on segment information can be found in the financial discussion in our 10-K.

Third, the 2019 consolidated loss attributable to Precigen shareholders of $322.3 million or $2.09 per share includes $116.2 million or $0.75 per share associated with the discontinued operations. We further incurred a noncash impairment charge of $29.6 million for the write-down of goodwill associated with our Trans Ova Genetics subsidiary.

As discussed, we've initiated efforts in 2020 to improve the financial performance of Trans Ova Genetics going forward.

In concluding the financial component of our call, I will again reiterate that Precigen is wholly committed to deploying our precious capital towards our highest value health care assets in 2020 and beyond. We look forward to providing regular updates as our targeted value-generating milestones are achieved.

I would now like to turn the call back to Helen for concluding remarks.

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Helen Sabzevari, Precigen, Inc. - President & CEO [5]

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Thank you, Tom. In closing our call today, I want to confirm our optimism about Precigen's potential to transform the health care landscape with our innovative and focused portfolio. I think you will agree that there has never been a more exciting and promising time at Precigen. As Precigen's CEO, you have my commitment to manage our company in a financially prudent, fiscally disciplined and transparent manner with the paramount goal of achieving our mission to bring novel treatment options to patients. If we do this, all of our stakeholders will benefit.

With that, we'll now open the line for questions. Operator, please begin.

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Questions and Answers

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Operator [1]

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(Operator Instructions) Our first question will come from Jason Butler of JMP Securities.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [2]

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Helen, first one, just on the UltraCAR-T trials for both 3005 and 3006, can you frame for us how we should think about the readouts later this year in terms of patient numbers and maturity of data? And maybe if not specifically in terms of numbers, then in terms of how it could inform next steps or potentially progression to pivotal studies?

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Helen Sabzevari, Precigen, Inc. - President & CEO [3]

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Thank you, Jason. Actually, we are very excited for this upcoming interim data. First of all, in regards to the ovarian cancer, the IP arm and in regard to the AML that we have non-lymphodepletion arm to report. As you might have seen in our slides, our trials currently are 3 plus 3 plus 3, there are 3 doses. And as we finish these doses, we obviously will be reporting on the safety and dose, which are the paramount aspects of the Phase I. But at the same token, as we have always emphasized what is the most important thing for us is also show that our manufacturing in vivo directing patients to show the persistence and also the expansion of T cells. So we are looking forward to show some of the interim data by the second half of 2020. And it's quite exciting for us as we go through this journey, and we continue to then expand these patients to Phase Ib.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [4]

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Great. And then I had a question on AG013 and the interim results upcoming. How should we think about the magnitude of treatment effect here in terms of what would be clinically important to patients? And then in terms of the oral mucositis endpoint, can you just talk to us about subjectivity of the endpoint and how you're controlling for that? And any expectations for either reduction in analgesic use or potential for prolong radiation dose?

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Helen Sabzevari, Precigen, Inc. - President & CEO [5]

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Absolutely. Thank you. So our -- actually, the AG013 is a very exciting program for the platform of ActoBio. As you know, that ActoBio platform uses our elective delivery mechanisms for delivering different proteins, specifically to the mucosal linings. In the case of the oral mucositis, this is a devastating disease especially after the treatment of head and neck cancer patients with chemo and radiation. There are tremendous ulcers in the mouth, which is quite painful, and currently, there is really no treatment for this.

In the Phase I of the study that was done, we have designed the [elastics] in such a way that it delivers a gene that protects and also stimulates the lining of the mucosal lining of the mouth. And we had a very exciting results in the first Phase I showing reduction in the ulcers and actually the level of the pain. And now we have entered and actually finished enrollment of the patients in 2019 in a Phase II that it's done in a randomized fashion. So there is a placebo arm versus the treatment arm, which is quite important. And one aspect that is quite exciting based on the Phase I data, FDA has given us a Fast Track for this indication currently. And this is -- would be the first proof of this platform actually for ActoBio, which we also have exciting trial ongoing in the T1D, type 1 diabetes, which we are anticipating to actually report on in second half of 2020 using a similar actually platform, but delivering a proinsulin, and as well as IL-10, which suppresses the immune system, but actually, it helps the onset of -- it reduces onset of diabetes, and we had a very encouraging preclinical data, the Phase I data and now the Phase IIa will be reported in second half.

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Jason Nicholas Butler, JMP Securities LLC, Research Division - MD and Senior Research Analyst [6]

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Okay, great. That's helpful. And then just 1 last financial question, and sorry if I missed this in the prepared comments. But should we expect any further reorganization charges? And if so, how should we think about those in terms of cash versus noncash spend?

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Helen Sabzevari, Precigen, Inc. - President & CEO [7]

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So currently, I think we are not expecting any further reorganization charges. And as we mentioned by the end of January, all the assets will transfer to Third Security, and currently, we do not expect anything in that lab.

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Operator [8]

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(Operator Instructions) Our next question will come from Swayampakula Ramakanth from H.C. Wainwright.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [9]

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This is RK from H.C. Wainwright. Helen, a couple of quick questions. For the non-oncology assets, AG019 and INXN-4001, what do you plan for these assets in the long term? The reason for that question is, as you can imagine, as these assets get into late-stage development, they could become cash-intensive because of the large clinical trials that you would need to conduct. Would these be assets that can become currency in terms of out licensing?

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Helen Sabzevari, Precigen, Inc. - President & CEO [10]

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Thank you, RK. Great question. So we agree. We have a portfolio of -- maybe I should just first give a few minutes on the reason that we have a portfolio that we have. The strength of our portfolio is that we are not a one-drug-product company. It becomes very important because when you are one-drug-product company, basically despite of what the science might be or might not be, you are committed somehow. Whereas the way we have arranged our portfolio is that it's in such a manner that we prioritize and make it go/no-go decision based on data, and we know the attrition of the portfolio. And therefore, it's very, very important that we keep a fiscal responsibility with very, very laser-focused decision-making to address our portfolio.

In regards to the assets that we have highlighted for this year, actually, this has been a principal factor behind it. We are looking at our data, we are evaluating the breadth of the data that comes in its totality. And then there will be decisions made that if these assets will go to the next levels of development or not. However, what is very important as the fourth pillar that I mentioned as part of our principle is a strategic partnership. And this is very, very important for us in our portfolio. And to your point, obviously, and I'm going to stress this over and over again. We will not take every asset forward ourselves. We will also look into strategic partnerships that will bring the most value for our shareholders. And I think this is a pillar for us that it would allow us to manage our portfolio accordingly and make the decisions with the right partners, with the right speed and with the right cash to make these things and move them forward. And definitely, as you have mentioned, this is one of our strategic responsibility and platforms that we have for these assets.

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Swayampakula Ramakanth, H.C. Wainwright & Co, LLC, Research Division - MD of Equity Research & Senior Healthcare Analyst [11]

See the original post here:
Edited Transcript of XON earnings conference call or presentation 2-Mar-20 10:30pm GMT - Yahoo Finance

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Despite revolutionising healthcare, advanced therapies pose significant challenges to regulators and their approval pathways. Credit: Shutterstock.

Advanced therapies, including cell and gene therapies, have revolutionised healthcare. Created by altering a patient, or donors, cells using novel gene editing tools, these highly personalised therapies provide the possibility of long-term, life-improving treatment that could even be curative.

This approach to treating conditions, often those that were previously viewed as untreatable, has been gaining significant momentum; there are now three approved gene therapies on the market and more and more studies are being conducted in the area.

In the UK alone, there was a 45% increase in the number of advanced therapy trials from 85 in 2018 to 127 in 2019, according to Innovate UKs Cell and Gene Therapy Catapults clinical trials database. Non-profit Alliance for Regenerative Medicines 2019 clinical trials report highlighted although there was stagnation in the numbers of studies in Europe, there has been a global increase of 32% between 2014 and 2018.

However, the uniqueness of these therapies creates significant challenges for the pharma industry, particularly for regulators and their existing approval and reimbursement methods. The Alliance for Regenerative Medicine European public policy senior director Annie Hubert explains: Because advanced therapies are very different from traditional pharmaceuticals, both in the way they are manufactured and in the potential therapeutic effect for patients, traditional regulatory pathways are often ill-suited to the regulation of advanced therapies.

Often these therapies are developed for rare disorders with small patient populations meaning there is less safety and long-term efficacy data available upon approval than regulators are used to with randomised control trials. It is also often not seen as ethical to recruit placebo arms for the types of severe conditions these diseases treat.

As a result of their durable and sometimes curative effects, these therapies have a high upfront cost Novartiss gene therapy for spinal muscular atrophy Zolgensma is priced at $2.1m per patient, making it the most expensive drug in the world.

The Alliance for Regenerative Medicines 2019 Getting Ready: Recommendations for Timely access to advanced therapy medicinal products in Europe report also notes this cost is also linked to the incredibly complex, manufacturing process required for advanced therapies. Hubert notes the different manufacturing process also poses a challenge for regulators when applying traditional quality control and other standards to the production of advanced therapies.

How can regulators support continued R&D and allow for the commercialisation and reimbursement of these ground-breaking therapies?

Despite regulators creating new pathways for quicker assessment and approval of these challenging, but innovative medicines, there still remain significant barriers to development, approval and reimbursement of these therapies.

Since randomised, placebo-controlled trials with clinically validated endpoints are not usually appropriate for advanced therapies, there is a need for regulators to be adaptive to the different types of trials, data and endpoints to support the approval of advanced therapies.

In terms of innovative trial design, Hubert notes regulators can help to facilitate this by enhancing the acceptability of validated surrogate endpoints to estimate long-term outcomes, as well as improving the infrastructure for gathering real-world evidence [RWE] to supplement traditional clinical trial data.

RWE can help to mitigate some of the uncertainty around the long-term, durable therapeutic benefits of these advanced therapies. However, it can also be used to collect so-called natural history data of trial participator to be used as the comparator for trials, meaning there is no need for a placebo trial arm.

A primary recommendation of Alliance for Regenerative Medicines 2019 report is to consider to new payment structures that take into account the longer-term value these therapies have on patients and their families, as well as the overall cost-savings to the healthcare systems.

Increased predictability in reimbursement determinations post-approval would also likely promote growth in clinical development, adds Hubert.

The non-profit recommends a range of different models, including conditional reimbursement, paying based on outcomes and annuity-based payments.

All of these models would be supported by more and easier RWE collection, but Hubert picks out conditional approval schemes as benefitting the most; RWE can help to offset the perceived risk of providing and reimbursing products with limited follow-up data available, while still ensuring patients can access safe and effective therapies as efficiently as possible.

Conditional reimbursement schemes involve temporary reimbursement, which is contingent on the collection and review of further evidence; an example of an existing model is NHS Englands Cancer Drugs Fund, and Boris Johnsons Conservative Government has expressed a desire to expand this into an Innovative Drugs Fund to include disease areas beyond oncology.

Outcome-based reimbursement models are similar, but they are specifically linked to certain pre-determined benefits of the drug the UKs Cell and Gene Therapy say these can be clinical, economic or patient-reported experience measures, and the best way to support them is through the development of interconnected data registries. The Pistoia Alliances 2030 retrospective report also discussed the need to move away from a pay-per-pill approach towards payments based on outcomes when dealing with personalised medicines.

Finally, annuitypayments can help to spread the cost of therapy out over several years Hubert explains. This allows healthcare providers to plan their resource allocation for the therapy, as well as facilitates affordable access. The Alliances recommendations-focused report finds that these have been discussed, but not yet implemented.

The central vision of both the Cell and Gene Therapy Catapult and the Alliance for Regenerative Medicine is to better connect all the groups involved in advanced medicine, ranging from patients, drug developers to regulators.

Dialogue between industry, researchers, regulators, and other stakeholders is essential to ensure that safe and effective next-generation therapies are able to reach patients in a timely manner.

This becomes even more important as new, even more complex therapies are being developed; early dialogue would allow regulators to prepare their processes in advance, rather than trying to catch up after the fact.

In addition, the Alliances Getting Ready report also notes the need for regulators to communicate with one another to create international standards. This makes it easier for developers looking to launch a product in multiple countries, as well as reducing duplicative or contradictive regulatory requirements, which can be particularly burdensome for smalldevelopers with limited resources which dominate this field, Hubert concludes.

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Tips and tricks for regulators regarding advanced therapies - Pharmaceutical Technology

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DENVER (KDVR) -- Even with a stay-at-home order in place, there was no way Amber Freed was cancelling her 3-year-old twins birthday party.

The Denver mother set up an entire partys worth of decorations in the front yard, complete with a giant blow-up dinosaur, and dozens of balloons.

What I did was pull out every seasons decorations all at once.We had Thanksgiving, dinosaurs, Halloween, and everything for a birthday, Freed said, laughing.

She asked friends and neighbors to drive by in their car and wish her twinsMaxwell and Rileyahappy birthday, by honking three times.

I am going to remember this day and smile so big, said Amber Freed.

The drive-by style party brought a few hours of joy to the Freed family, during an otherwise time of darkness.

I definitely was up late last night, trying to piecemeal this party together, knowing that this might be Maxwells last healthy birthdayand also knowing that all the progress we made may be falling apart right now, said Freed, with tears in her eyes.

Maxwell suffers from a rare, genetic disorderso rare, in fact, it doesnt have a real name.For now, its referred to as SLC6A1 and is similar to Parkinsons disease.

In the next year, were expecting a debilitating form of epilepsy to begin, that is not treatable with drugs.His 4th birthdayhe may lose a lot of the skills he has fought so hard to gain, Freed said.

A drug, and possible cure, is already being tested on mice.

Gene therapy was set to start later this year, but the timeline has slowed down significantly in the face of the COVID-19 pandemic.

Only a few scientists can be in laboratory at a time, and a lot of students and PhDs were working on our projectsand universities have shut down, Freed explained.Because universities have shut down, there are just no resources, she added.

Its a devastating setback for her son.

Days and minutes count for us.We need to have him treated soon, or else he will have no quality of life.

Theyll still need an additional $3.5 million, minimum, to conduct a full clinical trailat a time where many Americans are now experiencing financial strain.

Im so deeply sad that we came this far, and everything was working out perfectly.I was fighting so hard to save my baby boy, and all of that is in complete limbo right now, Freed said.

Which is why Saturday was much more than just a party, in her eyes.

I cannot believe how many people showed up to support Maxwell and Riley.It made the day so special for us.And it just meant the entire world for my family.

Learn more on Milestones for Maxwell or donate to help the family fund research and a clinical trial.

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Drive-by birthday party for 3-year-old with rare disease - FOX 31 Denver

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NEW YORK and CLEVELAND, March 27, 2020 (GLOBE NEWSWIRE) -- The COVID-19 pandemic has created extraordinary challenges across all aspects of healthcare. Many institutions and their brave staff of providers are now focused on caring for patients stricken by the virus. We at Abeona are thankful for their sacrifices and efforts, and stand behind these healthcare institutions whose resources are focused on the greater good. We are dedicated to being a good global citizen in doing our part by following guidance from local health officials in New York, Cleveland, and Madrid, and where remote employees reside.

Above all, we will take every reasonable measure to ensure the safety of our patients and employees, while sustaining our business operations during this uncertain time. Abeona is fully focused on getting through the pandemic by working closely with our clinical trial sites to ensure that patient safety remains paramount.

Clinical DevelopmentWe remain committed to advancing our clinical programs, but recognize delays are inevitable in these uncertain times, especially as healthcare resources are justly redirected to those who need them most. We are continually assessing the dynamic situation and implementing plans to minimize disruption. We are also constantly reviewing these plans and associated processes and policies to ensure our patients and employees are safe, and continuity in our scaled back operations remains.

While the full impact on our clinical programs cannot be quantified at this point, what we do know is that all current clinical trial sites remain active. We can say with certainty that some sites have paused screening and delays are expected as the situation evolves globally. What we wont know for the foreseeable future is the long-term impact. However, we remain dedicated to communicating frequently and openly with our stakeholders as more information becomes available, including updates on material changes to prior guidance as we continue to follow applicable government, regulatory and institutional guidelines.

Business OperationsLooking inward, the safety of our employees is a top priority. We have instituted additional protective measures since news of COVID-19 broke, and we frequently assess and improve our safety practices and policies. Operations at our Cleveland manufacturing facility have been significantly scaled back to ensure that employees and those around them have the best chance to remain safe, and to accommodate reduced clinical development activities. Only employees deemed essential by senior management to maintaining the manufacturing operation are entering the facility and under strict safety protocols to mitigate their risk. More traditional means of risk mitigation including a global work from home policy and suspended business travel are also in place.

As we try to rationalize the unprecedented developments sweeping the globe, please be assured that Abeona is doing all it can to protect our patients, employees, and the communities around us. This includes company operations that underpin our aspirations to bring new medicines to patients in need.

Abeona is about great Science and great People, and its important we continue to do everything we can to preserve both.

We will get through this but only if we work together.

About Abeona TherapeuticsAbeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Companys clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively. The Companys portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Abeona has received numerous regulatory designations from the FDA and EMA for its pipeline candidates, including Regenerative Medicine Advanced Therapy designation for two candidates (EB-101 and ABO-102). http://www.abeonatherapeutics.com

Investor Contact:Dan FerryLifeSci Advisors, LLC+1 (617) 535-7746 daniel@lifesciadvisors.com

Media Contact:Scott SantiamoDirector, Corporate CommunicationsAbeona Therapeutics+1 (718) 344-5843 ssantiamo@abeonatherapeutics.com

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Abeona Therapeutics Stakeholder Letter in Response to the COVID-19 Pandemic - Associated Press

Nomura analyst Christopher Marai maintained a Buy rating on Voyager Therapeutics (VYGR) on March 27 and set a price target of $16.00. The companys shares closed last Friday at $9.05, close to its 52-week low of $6.27.

According to TipRanks.com, Marai is a 2-star analyst with an average return of -0.6% and a 43.7% success rate. Marai covers the Healthcare sector, focusing on stocks such as Global Blood Therapeutics, Alexion Pharmaceuticals, and BioMarin Pharmaceutical.

Currently, the analyst consensus on Voyager Therapeutics is a Moderate Buy with an average price target of $19.67, implying a 129.5% upside from current levels. In a report issued on March 19, Benchmark Co. also initiated coverage with a Buy rating on the stock.

See todays analyst top recommended stocks >>

Based on Voyager Therapeutics latest earnings release for the quarter ending December 31, the company reported a quarterly revenue of $32.67 million and GAAP net loss of $12.57 million. In comparison, last year the company earned revenue of $2.01 million and had a GAAP net loss of $22.53 million.

TipRanks has tracked 36,000 company insiders and found that a few of them are better than others when it comes to timing their transactions. See which 3 stocks are most likely to make moves following their insider activities.

Voyager Therapeutics, Inc. operates as a clinical-stage gene therapy company, which develops treatments for patients suffering from central nervous system. Its pipeline of gene theraphy programs include VY-AADC, VY-SOD101, VY-HTT01, VY-FXN01, Tau Program, and VY-NAV01. The company was founded by Guangping Gao, Mark A. Kay, Krystof Bankiewicz and Phillip Zamore in June 2013 and is headquartered in Cambridge, MA.

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Nomura Sticks to Its Buy Rating for Voyager Therapeutics (VYGR) - Smarter Analyst

CAMBRIDGE, Mass.--(BUSINESS WIRE)--bluebird bio, Inc. (NASDAQ: BLUE) today provided an update in response to the global COVID-19 pandemic. The company has taken steps to ensure the safety of its patients and employees, while working to ensure the sustainability of its business operations as this unprecedented situation continues to evolve.

The COVID-19 pandemic has created new challenges for bluebird, the broader biotech community, and society as a whole. During this unprecedented time, we remain focused on caring for the patients who rely on us, said Nick Leschly, chief bluebird. In addition, we are prioritizing the safety and well-being of our employees, making a positive impact as a member of our local community, and continuing to execute on our business strategy. While we all face tremendous challenges and uncertainty at this time, I am confident in bluebirds ability to face these headwinds with ingenuity, empathy, and a relentless commitment to the people we serve.

bluebird bio continues to evaluate the impact of COVID-19 on the healthcare system and work with healthcare providers supporting its clinical studies to mitigate risk to patients while taking into account regulatory, institutional, and government guidance and policies. The company remains committed to maintaining its development plans but acknowledges the potential impact on clinical studies given the rapidly evolving global environment. Generally, the company expects the COVID-19 pandemic to shift the timing of enrollment and completion of clinical studies by at least three months and expects timing shifts to vary by clinical trial and by program.

Regulatory Activities

Commercial Launch of ZYNTEGLO

Operating PlanIn light of the impacts of the COVID-19 pandemic on the business and the anticipated changes to commercial, regulatory and development timelines, the company is currently re-evaluating its operating plan. The company will be adjusting priorities and overall expenses. An update will be provided by the companys Q1 2020 earnings release.

Ongoing Programs and Clinical StudiesBelow is the current status of bluebird bio sponsored clinical trials:

Our People and Businessbluebird bio is evaluating all business-critical actions to determine how best to mitigate risk while being as minimally disruptive as possible. Safety of bluebird bio employees remains a top priority for the company. As of March 10, the company transitioned to a global work from home policy. Business-critical laboratory, manufacturing and related support activities continue and have been subject to heightened precautions to ensure safety of employees and the continuation of highest priority activities. The company continues to assess company policies, business continuity plans and employee support.

Conference Call DetailsInvestors may listen to the call on March 26, 2020 at 8:30 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 2666529.

To access the live webcast of bluebird bios presentation, please visit the Events & Presentations page within the Investors & Media section of the bluebird bio website at http://investor.bluebirdbio.com. Replays of the webcast will be available on the bluebird bio website for 90 days following the event.

About bluebird bio, Inc.

bluebird bio is pioneering gene therapy with purpose. From our Cambridge, Mass., headquarters, were developing gene therapies for severe genetic diseases and cancer, with the goal that people facing potentially fatal conditions with limited treatment options can live their lives fully. Beyond our labs, were working to positively disrupt the healthcare system to create access, transparency and education so that gene therapy can become available to all those who can benefit.

bluebird bio is a human company powered by human stories. Were putting our care and expertise to work across a spectrum of disorders including cerebral adrenoleukodystrophy, sickle cell disease, -thalassemia and multiple myeloma, using three gene therapy technologies: gene addition, cell therapy and (megaTAL-enabled) gene editing.

bluebird bio has additional nests in Seattle, Wash.; Durham, N.C.; and Zug, Switzerland. For more information, visit bluebirdbio.com.

Follow bluebird bio on social media: @bluebirdbio, LinkedIn, Instagram and YouTube.

ZYNTEGLO, LentiGlobin, Lenti-D and bluebird bio are trademarks of bluebird bio, Inc.

The full common name for ZYNTEGLO: A genetically modified autologous CD34+ cell enriched population that contains hematopoietic stem cells transduced with lentiviral vector encoding the A-T87Q-globin gene.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the companys financial condition, results of operations, as well as statements regarding the plans for development and commercialization for ZYNTEGLO and the companys product candidates, including plans for our ongoing clinical trials, expectations regarding timing for the first patient treated with ZYNTEGLO in the commercial context, our plans and timing expectations for regulatory submissions for ide-cel, LentiGlobin for -thalassemia, LentiGlobin for SCD, and Lenti-D for CALD, our plans for data disclosures in 2020, and our plans and expectations in light of and in response to the COVID-19 pandemic and its impacts on global healthcare systems and our business. Any forward-looking statements are based on managements current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risks that the COVID-19 pandemic may disrupt our business and/or the global healthcare system more severely than we have anticipated, which may have the effect of further delaying our ability to enroll and complete our ongoing clinical trials (which may include potential delays of the ide-cel clinical trials beyond April 13, 2020), further delaying our ability to treat the first patient in the commercial context and obtaining market access and reimbursement for our approved product, and further delaying our timelines for regulatory submissions for our product candidates; the risk that we will encounter further challenges in the commercial launch of ZYNTEGLO in the European Union, including in managing our complex supply chain for the delivery of drug product, in the adoption of value-based payment models, or in obtaining sufficient coverage or reimbursement for our products; the risk that our collaborations, including the collaborations with Bristol-Myers Squibb, will not continue or will not be successful; and the risk that any one or more of our product candidates, will not be successfully developed, approved or commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled Risk Factors in our most recent Form 10-K, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

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bluebird bio Provides Assessment of Impact of COVID-19, Update on Business Operations and Clinical Program Development - Business Wire

- New company formed from combination of TranscripTx and ReCode Therapeutics

- Advancing mRNA-mediated protein replacement and tRNA NanoCorrector therapies for primary ciliary dyskinesia and cystic fibrosis

- Developing proprietary non-viral lipid nanoparticle delivery platform for organ-specific delivery of RNA therapies and gene editing components

MENLO PARK, Calif. & DALLAS--(BUSINESS WIRE)-- ReCode Therapeutics (ReCode) (the Company), a private biopharmaceutical company pioneering precision medicines for pulmonary diseases, today announced the close of an oversubscribed $80 million Series A financing round. OrbiMed Advisors LLC and Colt Ventures co-led the round, with participation from MPM Capital, Vida Ventures LLC, Hunt Technology Ventures, L.P. and Osage University Partners. ReCode will use the proceeds to continue the preclinical development of its lead programs in primary ciliary dyskinesia (PCD) and cystic fibrosis (CF). The Company expects to file an Investigational New Drug Application (IND) for both programs in 2021. In addition, the Company will advance its proprietary non-viral lipid nanoparticle (LNP) delivery platform for organ-specific delivery of RNA therapies and gene editing components.

Our preclinical studies demonstrate that our targeted RNA therapies have great potential for the treatment of life-threatening pulmonary diseases, commented David Lockhart, Ph.D., CEO and president, ReCode Therapeutics. We are pleased to close this financing round with world-class investors who believe in the bold vision of our new company. With these additional resources, were focused on advancing our preclinical programs into the clinic over the next two years.

Lockhart continued, Im especially grateful to ReCodes founders, professors Daniel Siegwart, Ph.D., and Philip Thomas, Ph.D., at the University of Texas Southwestern Medical Center, and Professor Emeritus Arthur Johnson from Texas A&M University whose foundational research played an instrumental role in cultivating both the LNP delivery platform and the CF therapeutic program. Finally, we are grateful to the Cystic Fibrosis Foundation, whose financial support has allowed us to play a pivotal role in understanding the pathogenesis of CF and led to the development of a novel therapeutic approach for correcting nonsense mutations for this severe disease.

Along with the financing, ReCode has appointed a new board of directors. The directors comprise representatives from the Company including Dr. David Lockhart and key investors including Dr. Peter Thompson, partner at OrbiMed, Ed Hurwitz, J.D., managing director at MPM Capital, Helen S. Kim, managing director at Vida Ventures, R.A. Session II, chief business officer of the gene therapy subsidiaries at BridgeBio, and ReCode founder and new vice president of R&D, Dr. Michael Torres.

We believe that ReCode has an exceptional opportunity to advance its targeted RNA therapies and LNP delivery platform to address the critical needs of patients living with devastating genetic respiratory diseases, said Dr. Peter Thompson, partner, OrbiMed. The board looks forward to supporting ReCodes evolution as it moves these compelling therapies into the clinic.

Chardan acted as sole placement agent on the Series A financing, and as M&A advisor to ReCode Therapeutics.

About ReCode Therapeutics

ReCode Therapeutics is a biopharmaceutical company developing precision medicines for genetic respiratory diseases with significant unmet medical need. ReCodes diverse pipeline includes lead programs for primary ciliary dyskinesia and nonsense mutations in cystic fibrosis. The Companys proprietary non-viral lipid nanoparticle platform enables the delivery of a variety of payloads, and precise organ targeting of nucleic acid and protein payloads via both systemic and local delivery. ReCode is leveraging its nanoparticle and nucleic acid technologies across multiple modalities, including mRNA-mediated protein replacement therapies, first-in-class tRNA NanoCorrectors for diseases caused by nonsense mutations, and gene editing. For more information, visit http://www.recoderx.com

About OrbiMed Advisors LLC

OrbiMed is a leading healthcare investment firm, with over $14 billion in assets under management. OrbiMed invests globally across the healthcare industry, from start-ups to large multinational corporations, utilizing a range of private equity funds, public equity funds, and royalty/credit funds. OrbiMed maintains offices in New York City, San Francisco, Shanghai, Hong Kong, Mumbai and Herzliya. OrbiMed seeks to be a capital provider of choice, providing tailored financing solutions and global team resources and support to help build world-class healthcare companies. To learn more, visit http://www.orbimed.com.

About Colt Ventures

Colt Ventures is a family office that was established in 2003 to invest the capital of Darren Blanton. Colt invests in a variety of private and public companies, and has deep domain expertise in biotechnology and energy. Dr. Sundeep Agrawal leads the firms investment activities with a focus on biotechnology/therapeutics. Colt is headquartered in Dallas with a presence in New York City. To learn more, visit http://www.coltventures.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200326005123/en/

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ReCode Therapeutics Raises $80 Million in Oversubscribed Series A Financing - BioSpace

Debates over the ethics of embryonic stem cell research have divided scientists, politicians, and religious groups for years.

However, promising developments in other areas of stem cell research have led to solutions that help bypass these ethical barriers and win more support from those against embryonic stem cell research; the newer methods don't require the destruction of blastocysts.

Many parties continue to have strong opinions that trigger ongoing debates about stem cell research, and the following pros and cons provide a snapshot of some the points on each side of the issue.

The excitement about stem cell research is primarily due to the medical benefits in areas ofregenerative medicineand therapeutic cloning. Stem cells provide huge potential for finding treatments and cures to a vast array of medical issues:

Different diseasesincluding cancers, Alzheimer's, Parkinson's, and morecan be treated with stem cells by replacing damaged or diseased tissue. This can include neurons that might affect neurological diseases and even entire organs that need to be replaced.

There is endless potential for scientists to learn about human growth and cell development from studying stem cells. For example, by studying how stem cells develop into specific types of cells, scientists potentially could learn how to treat or prevent relevant ailments.

One of the areas of potential is embryonic treatment. This stage of pregnancy is when many birth defects or other potential issues begin. Studying embryonic stem cells possibly could lead to a better understanding of how embryos develop and maybe even lead to treatments that can identify and address potential problems.

Because the cells can replicate at a high rate, a limited number of initial cells eventually can grow into a much greater number to be studied or used in treatment.

Medical benefits such as regenerating organ tissue and therapeutic cell cloning

May hold the answer to curing various diseases, including Alzheimer's, certain cancers and Parkinson's

Research potential for human cell growth and development to treat a variety of ailments

Possibility of use for embryonic treatment

Requires only a small number of cells because of the fast replication rate

The difficulty of obtaining stem cells and the long period of growth required before use

Unproven treatments often come with high rejection rates

Cost can be prohibitive for many patients

Ethical controversy over use of stem cells from lab-fertilized human eggs

Additional ethical issues regarding the creation of human tissues in a lab, such as cloning

Stem cell research presents problems like any form of research, but most opposition to stem cell research is philosophical and theological, focusing on questions of whether we should be taking science this far:

It's not easy to obtain stem cells. Once harvested from an embryo, stem cells require several months of growth before they can be used. Obtaining adult stem cells, such as from bone marrow, can be painful.

As promising as the field is, stem cell treatments still are unproven, and they often have high rejection rates.

The cost also can be prohibitive for many patients, with a single treatment costing well into the thousands of dollars, as of 2018.

The use of embryonic stem cellsforresearchinvolves the destruction of blastocysts formed from laboratory-fertilized human eggs. For those who believe that life begins at conception, the blastocyst is a human life, and to destroy it is unacceptable and immoral.

A similar theological problem is an idea of creating living tissue in a laboratory and whether that represents humans taking on the role of God. This argument also applies to the potential for human cloning. For those who believe God created people, the prospect of people creating people is troublesome.

In 1998, the first published research paper on the topic reported that stem cells could be taken from human embryos. Subsequent research led to the ability to maintain undifferentiated stem cell lines (pluripotent cells) and techniques for differentiating them into cells specific to various tissues and organs.

The debates over the ethics of stem cell research began almost immediately in 1999, despite reports that stem cells cannot grow into complete organisms.

In 20002001, governments worldwide were beginning to draft proposals and guidelines to control stem cell research and the handling of embryonic tissues and reach universal policies. In 2001, the Canadian Institutes of Health Research (CIHR) drafted a list of recommendations for stem cell research. In the U.S., the Clinton administration drafted guidelines for stem cell research in 2000. Australia, Germany, the United Kingdom, and other countries followed suit and formulated their own policies.

Debates over the ethics of studying embryonic stem cells continued for nearly a decade until the use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)became more prevalent and alleviated those concerns.

In the U.S. since 2011, federal funds can be used to study embryonic stem cells, but such funding cannot be used to destroy an embryo.

Use of adult-derived stem cellsknown as induced pluripotent stem cells (IPSCs)from blood, cord blood, skin, and other tissues have been demonstrated as effective in treating different diseases in animal models. Umbilical cord-derived stem cells obtained from the cord blood also have been isolated and used for various experimental treatments. Another option is uniparental stem cells. Although these cell lines are shorter-lived than embryonic cell lines, uniparental stem cells hold vast potential if enough research money can be directed that way: pro-life advocates do not technically consider them individual living beings.

Two recent developments from stem cell research involve the heart and the blood it pumps. In 2016, researchers in Scotland began working on the possibility of generating red blood cells from stem cells in order to create a large supply of blood for transfusions. A few years earlier, researchers in England began working on polymers derived from bacteria that can be used to repair damaged heart tissue.

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Pros and Cons of Stem Cell Research - ThoughtCo

Triple-negative breast cancer is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein.

These results mean the growth of the cancer is not fueled by the hormones estrogen and progesterone, or by the HER2 protein. So, triple-negative breast cancer does not respond to hormonal therapy medicines or medicines that target HER2 protein receptors. Still, other medicines are used to successfully treat triple-negative breast cancer.

About 10-20% of breast cancers are triple-negative breast cancers. For doctors and researchers, there is intense interest in finding new medications that can treat this kind of breast cancer. Studies are trying to find out whether certain medications can interfere with the processes that cause triple-negative breast cancer to grow.

Cell receptors are special proteins found inside and on the surface of cells. These receptor proteins are the eyes and ears of the cells, receiving messages from substances in the bloodstream and then telling the cells what to do.

Hormone receptors inside and on the surface of healthy breast cells receive messages from the hormones estrogen and progesterone. The hormones attach to the receptors and provide instructions that help the cells continue to grow and function well. Most, but not all, breast cancer cells also have these hormone receptors. Roughly two of three breast cancers test positive for one or both of these hormone receptors. (For a more complete explanation, see the Hormone Receptor Status page.)

A smaller percentage of breast cancers about 20% make too much of the HER2 protein. In normal, healthy breast cells, the HER2 stimulates cell growth. When breast cancer cells have too much of the HER2 protein, however, the cells grow and divide too quickly. (For a more complete explanation, see the HER2 Status page.)

Hormonal therapies and HER2-targeted therapies disrupt the effects of estrogen, progesterone, and the HER2 protein on breast cancer, which can help slow or even stop the growth of breast cancer cells.

About 10-20% of breast cancers test negative for both hormone receptors and excess HER2 in the lab, which means they are triple-negative. Since hormones arent fueling the cancers growth, the cancer is unlikely to respond to hormonal therapy medicines, including tamoxifen and aromatase inhibitors. Triple-negative breast cancer also is unlikely to respond to medicines that target the HER2 protein, such as Enhertu (chemical name: fam-trastuzumab-deruxtecan-nxki), Herceptin (chemical name: trastuzumab), Kadcyla (chemical name: T-DMA or ado-trastuzumab emtansine), Nerlynx (chemical name: neratinib), Perjeta (chemical name: pertuzumab), or Tykerb (chemical name: lapatinib).

Three common features of triple-negative breast cancer

Who gets triple-negative breast cancer?

Anyone can be diagnosed with triple-negative breast cancer. Still, researchers have found that it is more common in:

If you are diagnosed with triple-negative breast cancer

It can be upsetting and scary to find out that youve been diagnosed with a type of breast cancer that is often more aggressive than other types and isnt a good candidate for treatments that target the hormone receptors or HER2 protein.

Still, its important to remember that the lack of hormone receptors and excess HER2 protein are just two factors that you and your doctor will take into consideration when deciding on a treatment plan. The stage and grade of the cancer are also crucial to your prognosis.

Its also important to remember there are therapies available that can treat triple-negative breast cancer.

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Triple-negative breast cancer is typically treated with a combination of surgery, radiation therapy, and chemotherapy.

Neoadjuvant chemotherapy

Research has shown that when triple-negative breast cancer is treated with chemotherapy before surgery what doctors call neoadjuvant chemotherapy and there is a pathologic complete response, disease-free survival and overall survival are better.

One way for doctors to judge the effectiveness of neoadjuvant treatment is to look at the tissue removed during surgery to see if any active cancer cells are present. If no active cancer cells are present, doctors call it a pathologic complete response or pCR.

Disease-free survival is how long a person lives without the cancer recurring. Overall survival is how long a person lives whether or not the cancer recurs.

PARP inhibitors

PARP inhibitors, such as Lynparza (chemical name: olaparib) and Talzenna (chemical name: talazoparib), have been approved to treat advanced-stage HER2-negative breast cancer in people with a BRCA1 or BRCA2 mutation.

The poly ADP-ribose polymerase (PARP) enzyme fixes DNA damage in both healthy and cancer cells. Research has shown that medicines that interfere or inhibit the PARP enzyme make it even harder for cancer cells with a BRCA1 or BRCA2 mutation to fix DNA damage. This makes it harder for the cancer cells to survive. In other words, a PARP inhibitor makes some cancer cells less likely to survive their DNA damage.

Immunotherapy

The immunotherapy medicine Tecentriq (chemical name: atezolizumab) in combination with the chemotherapy medicine Abraxane (chemical name: albumin-bound paclitaxel or nab-paclitaxel) is approved as a first treatment for unresectable locally advanced or metastatic triple-negative, PD-L1-positive breast cancer.

Immunotherapy medicines work by helping your immune system work harder or smarter to attack cancer cells. Tecentriq is an immune checkpoint inhibitor medicine, which means it targets a specific protein that helps cancer cells hide from the immune system, in this case, the PD-L1 protein. By inhibiting PD-L1, Tecentriq essentially allows immune system cells to see the cancer cells and kill them.

You can visit Treatment and Side Effects for more information about surgery, radiation therapy, chemotherapy, targeted therapies such as PARP inhibitors, and immunotherapy.

Clinical trials using these and other therapies could play a key role in improving the treatment of triple-negative breast cancer. Talk to your doctor if you think you might be interested in taking part in a clinical trial.

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Your Guide to the Breast Cancer Pathology Report is an on-the-go reference booklet you can fill out with your doctor or nurse to keep track of the results of your pathology report. Order a free booklet by mail or download the PDF of the booklet to print it at home.

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Triple-Negative Breast Cancer: Overview, Treatment, and More

The development of bone marrow transplantation procedures is widely considered one of the greatest victories in the war against cancer. The vast majority of bone marrow transplant recipients are patients with various forms of blood cancers, such as leukaemia, lymphoma or multiple myeloma. A real game changer, bone marrow transplantation has boosted survival rates for some blood cancers from nearly zero to over 85%.

Unfortunately, however, patients receiving bone marrow transplants are at high risk of developing Graft versus Host Disease (GvHD), a life-threatening complication that occurs when the transplanted cells from the donor the graft identify the transplant recipient the host as foreign.

This triggers an immune reaction that can wreak havoc in the transplanted patients body as it is attacked by the donated cells. This can occur from just days (in the case of acute GvHD) up to months or years (for chronic GvHD) after the haematopoietic cell transplantation (HCT) procedure has taken place.

The mortality rate of acute GvHD is very high in the case of grade 4 GvHD, it is over 90%. The overwhelmingly positive preliminary response of patients to CBD in preventing and treating GvHD shown in early trials, could be the key to significantly decreasing the incidence of this terrible condition.

Before we go on, there is a distinction to be made between a transplant rejection, which occurs when the immune system of the transplant recipient rejects the transplanted tissue, as may be the case in liver or heart transplants, and GvHD, which occurs when the while blood cells in the donors reject the recipient.

There are two types of bone marrow transplant: autologous (from the patients own stem cells) and allogeneic (stem cells from a donor). It is in the latter where GvHD may occur.

GvHD from allogeneic bone marrow transplants can manifest itself in many forms and degrees; ranging from mild, moderate or severe, to potentially fatal for the patient. Acute GvHD can cause rashes and blistering of the skin, nausea, vomiting, abdominal cramps accompanied by diarrhoea, jaundice; and may attack the lungs, liver and eyes. It is often associated with chronic illness, infections, disability, reduced quality of life, and is a major cause of morbidity and mortality following HCT.

Researchers estimate that despite aggressive preventive measures with immunosuppressive treatments, 30% to 50% of transplanted patients whose donors were fully matching siblings and 50% to 70% of patients whose donors were unrelated to them develop some level of GvHD.

Though it may sound surprising, currently there are no FDA approved therapies for either the prevention or treatment of acute GvHD.

Enter Kalytera Therapeutics, a clinical-stage pharmaceutical company aiming to develop cannabidiol (CBD) for the treatment of serious diseases. The companys drug development expertise and intellectual property portfolio put it at the forefront in the development of CBD-based medicines for a range of important unmet medical needs. Currently, its resources are being focused mainly on mitigating the effects of GvHD following bone marrow transplantation.

Kalytera Therapeutics lead programme, in which we are evaluating CBD for the prevention and treatment of GvHD, is in late-stage clinical testing. Kalytera Therapeutics have an ongoing open label Phase 2 clinical study to evaluate the pharmacokinetic profile, safety and efficacy of CBD for the prevention of acute GvHD with encouraging preliminary results; we are currently approaching the end of cohort 2. A series of Phase 1 studies requested by the FDA, such as the effect of food intake on the absorption of oral CBD, have also been completed.

At this stage, Kalytera Therapeutics are ready to plan a meeting with the FDA to discuss the possibility of starting a pivotal study later this year. Following the approval of Epidiolex for Dravet Syndrome by GW Pharma, the FDA has encouraged that Kalytera apply for a 505(b)2 regulatory pathway, which provides manufacturers of some types of drugs to apply for FDA approval without performing all the work required in a new drug application.

Kalytera Therapeutics have also received a Fast Track Designation to aid in the development and expedite review of drugs intended for serious or life-threatening disease and addressing an unmet medical need, for the companys CBD products for prevention and treatment of acute GvHD. This could accelerate the approval process for these products.

The obvious first step in attempting to prevent GvHD is to find donor cells that match the genetics of the immune system of the transplant recipient as closely as possible. But even in the ideal case of the donors being a sibling, the patient still must rely on drugs specially developed to cause immunosuppression of the donor cells, through either T-cell depletion or drugs. Treatments usually used for this include methotrexate, cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil and antithymocyte globulin (ATG), as determined by each medical team and institution.

When it comes to treating GvHD, the grafts immune cell activation needs to be suppressed with medication, so that donor-host immune tolerance can be established once again. Most patients are given corticosteroids, which directly suppress the donors immune cell attack on the hosts tissues. This also raises the risk of infection and the relapse of cancer.

As of now, there are guidelines but there is no standard treatment for either prevention or treatment of acute GvHD. Only 30% to 50% of patients with moderate to severe GvHD respond to corticosteroids, leaving many at risk of fatal outcomes. Everyone in the healthcare system should be aware that more research is necessary to discover better treatment options to reduce the rates of mortality and morbidity in transplantation patients.

The programme Kalytera is now implementing is based on previous Phase 2a clinical trials, which showed outstanding preliminary results in the prevention of the disease by giving patients CBD orally. In the first study, 48 patients received CBD for seven days prior to the bone marrow transplant procedure and for 30 days thereafter, as opposed to a group of 101 historical controls who had been given the usual GvHD prophylaxis and treated in the same BMT unit by the same medical team.

Remarkably, results showed none of the 48 patients had developed acute GvHD in the 30 days of treatment with CBD. Those who developed GvHD did so within a median time of 60 days, whereas the control group of 101 historical controls began to develop acute GvHD in a median time of 20 days only (ranging from nine to 137).

In the CBD treated group, the rates of grade 2 to grade 4 acute GvHD by day 100 were 12.1%, compared with 46% in the control. The rate of severe grade 3 to grade 4 was 5%, compared to 10% in the control. Equally important is the finding that CBD was also safe and well tolerated, with no severe adverse events attributed to its consumption. This is consistent with safety data previously reported on CBD administered to humans, even with three to four times higher doses and even when taken over extended periods of time.

In light of these encouraging initial results, it was decided to test the efficacy of a prolonged treatment covering 100 days: the time window in which acute GvHD usually occurs. In a second study, 12 patients were administered CBD at the same dose starting from seven days before the bone marrow transplant procedure until 100 days post-transplantation. No safety issues were observed here either and only one noncompliant patient, representing 8% of the CBD treatment group, developed acute GvHD; compared to a 46% incidence at the same institution in the historical group of 101 patients described above. This is despite the fact that the majority of the patients (10 out of 12) received stem cells from unrelated donors, including five patients who received stem cells from non-fully matched donors, which would normally increase their chance of developing GvHD.

In a third Phase 2a study, which was performed for treatment of already sick patients, 10 patients with acute GvHD, who were refractory to standard treatment with high dose steroids (only 60% of patients respond to first line therapy with high dose steroids), were administered daily doses of CBD for up to three months. Strikingly, nine of the 10 patients enrolled in the study responded to treatment, seven of them achieving complete remission of GvHD and two more achieving a near-complete response.

These results are impressive when we take into account that the 12-month mortality rate among patients with grade 3 and grade 4 GvHD who do not respond to steroids exceeds 60% and 80%, respectively. Indeed, these preliminary results compare favourably with the results of the historical control group of 29 patients with steroid-refractory grades 3 and 4 GvHD, among which 26 patients died from GvHD and its complications.

With a median follow-up period of 13 months, six patients were still alive. Two patients died from leukaemia relapses, and two patients died from GvHD-related infectious complications. No patient deaths were determined to be associated with CBD treatment. This underlines the urgency of developing a product that can prevent and treat GvHD.

On the list of the 10 most expensive medical procedures, allogeneic BMT ranked fourth; while autologous BMT, at less than half the outrageous cost, still made it to the eighth place. Depending on the country and institution, costs range from tens of thousands to hundreds of thousands of dollars per procedure. The need and incentive to increase the rate of success are indisputable.

The life-saving ability of Kalyteras CBD products for the prevention and treatment of acute GvHD, currently classified as an orphan disease, means the company has good chances of obtaining premium pricing for a course of treatment. Over 20,000 patients suffer from acute GvHD following bone marrow transplantation in the six major markets of the US, Germany, the UK, France, Spain and Japan every year.

According to the January 2018 Market Forecast Report by DelveInsight Perspective, the potential market for a successful drug for prevention and treatment of GvHD in the seven major jurisdictions of the US, Germany, France, Italy, Spain, the UK and Japan is estimated to be over $408m in 2018; and could grow to approximately $1.3bn by 2027.

Once Kalyteras CBD products are approved by the FDA, the company believes that treating physicians would not be expected to prescribe anything other than its approved formulation of CBD (as opposed to a non-approved CBD that might be available online or from other commercial sources), especially since patients are often in isolation in the intensive care unit. It is safe to assume that neither private insurance nor government provided healthcare reimbursement would be available for non-prescription generic CBD in the jurisdictions where Kalytera intends to market its CBD product.

Conducting proper, large scale clinical trials with CBD is of utmost importance. Although in some areas CBD seems to be generally safe in the broader healthy population, it can be harmful to some groups, such as young adults, women of childbearing age, pregnant women, children, people with known heart conditions or low blood pressure, and the elderly.

Despite all the hype about the multiple health benefits of cannabis-based products trumpeted by many (though not clearly stated due to possible risks of liabilities for unsubstantiated claims), so far only one CBD-based drug has received FDA approval for the treatment of two rare and serious types of epilepsy.

Contrary to popular belief and anecdotal evidence, CBD is not a biologically inert compound. Rather, CBD has a complex pharmacokinetic and pharmacodynamic profile similar to any other medication with the potential to interact with other medications and medical conditions. CBD is metabolised in the liver by enzymes responsible for metabolising a large percentage of other drugs. When taken concomitantly, CBD may reduce or neutralise the intended action of those other medications. Kalytera has completed drug to drug interaction testing in vitro and is now planning to start testing in healthy subjects.

CBD oil can have negative side effects too, such as drowsiness, drop in blood pressure when taken in large doses, being potentially harmful for people with low blood pressure. Other problems are dizziness or light-headedness, appetite changes, diarrhoea, hormonal changes, hypokinesia and resting tremor when used for epilepsy. In psychotic disorders it has side effects too, but they are milder than on other drugs used until today. It can benefit some Parkinsons patients, but not all of them.

Kalytera has a solid, experienced leadership team and very strong intellectual property portfolio. We have three issued US and European patents covering the use of CBD in the prevention and treatment of GvHD, as well as four orphan drug designations for the treatment and prevention of GvHD in the US and Europe.

Our promising preliminary results indicate we will be able to help BMT patients and their donated bone marrow get along better. This will greatly improve patients quality of life, productivity and life expectancy by keeping them GvHD free.

Dr Sari SagivStero Biotechs+972 36176173david@sela.co.il

Please note: Kalytera Therapeutics Inc. have recently acquired Stero Biotechs.

This article will appear in the second issue ofMedical Cannabis Network which will be available to read in April 2020.

Read more:
Kalytera Therapeutics: improving bone marrow transplants with CBD - Health Europa